Abstract: Medical devices and methods for diagnostic data collection and transmission are described.

Abstract: A laminated capillary array assembly having a plurality of capillaries substantially entirely enclosed by a first and a second substrate laminated together. Also disclosed is a capillary array electrophoresis system including the above capillary assembly attached to a sample intake block and an array fitting. Also described is a method for making a laminated capillary array assembly by placing a first substrate on a template having a desired shape, arranging capillaries on the first substrate, and laminating a second substrate on the first substrate to enclose the capillaries between the substrates.

Abstract: This invention relates to methods of assaying one or more analytes simultaneously. The assays of this invention are capable of providing wide dynamic range and rapid processing times. A wide dynamic working range is achieved by simultaneously incubating a sample which may contain the analyte(s) of interest with two or more independently determinable classes of particles coated with an analyte-specific binding partner. The two or more particle classes differ from each other at least in size. The analyte concentration is obtained from readings derived from these two classes by means of a combined standard curve.

Abstract: This invention provides &bgr;-D-Glucuronidase substrates of the formula: wherein R1, R2, and R7-R12 are independently selected from the group consisting of: hydrogen, fluorine, chlorine, bromine, iodine, alkyl, hydroxyl, alkoxy, carboxyl and nitro groups; R3-R6 are independently selected from the group consisting of hydrogen, fluorine, chlorine, bromine, iodine, nitro and amino; and M+ is selected from the group consisting of: proton, lithium, sodium, potassium, magnesium, calcium, barium, and ammonium ion.

Abstract: A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference.

Abstract: A fluid-moving device with an integrated valve is disclosed. The device includes a housing defining a suction chamber and at least one internal passageway formed inside the housing. A first end of the internal passageway opens to the suction chamber and a second end of the internal passageway connects to an outside surface of the housing. The fluid-moving device of the present invention also includes a pumping structure disposed inside the suction chamber for generating a pressure inside the suction chamber. The device may also include valve passageways formed inside the housing. In one embodiment, a manifold is utilized for connecting the valve passageways to fluid supplies and fluid sinks. The manifold has a casing, at least one input port, at least one output port, and a plurality of internal manifold passageways formed in the manifold casing. A method of making a fluid-moving device with an integrated valve of the present invention is also disclosed.

Abstract: Methods for detecting BRCA1 mutations are provided. The methods include the steps of determining the amount of the BRCA1 polypeptide contained in a sample of the subject, and correlating the amount of BRCA1 to the presence of the BRCA1 gene mutation in the subject, wherein the amount below a predetermined cutoff value is an indication of the presence of the mutation in the BRCA1 gene of the subject. The methods of the present invention are well suited for use to determine a condition associated with BRCA1 mutation, such as a predisposition to breast cancer, ovarian cancer, colorectal, and prostate cancers, and the presence or prognosis of breast cancer, ovarian cancer, colorectal, and prostate cancers.

Abstract: A lithium ion-selective membrane that favors the bonding of lithium and depresses sodium interference is invented by a charge balance approach. A lithium ion-selective electrode (Li-ISE) having the membrane of this invention demonstrates a fast kinetic response, good precision and reproducibility, high sensitivity and the ability to retain the sensitivity after a long-term contact with biological samples. The sensor shows Nernst linearity with a slope of 55.4 mV for lithium ion concentrations between 0.5 &mgr;mol/L and 10 mmol/L. The membrane includes at least about 2% by weight of 6,6-dibenzyl-1,4,8,11 tetraoxacyclotetradecane ionophore; from about 0.025% to about 1% by weight of potassium tetrakis(4-chlorophenyl)borate additive; a plasticizer; and a polymeric material.

Abstract: A substantially pure and isolated novel form of prostate specific antigen (PSA) is provided. The novel form of PSA of the present invention comprises at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA. Preferably, the novel form of PSA additionally comprises one or more clips at a location selected from a group consisting of Ile 1, Lys 145, and Lys 146. More preferably, the form of PSA contains at least two clips at Lys 145 and Lys 182 of the amino acid sequence of a mature form of PSA. The novel forms of PSA exist at an elevated level in patients suspected of having benign prostatic hyperplasia (BPH) and therefore may be used as a serum mark or an immunohistological marker to help distinguish BPH from prostate cancer. Antibodies recognizing the novel forms of PSA and immunoassays that detect and determine the novel forms of PSA of the present invention in a sample are also provided.

Abstract: The present invention provides a novel complex of hK2 and PI-6 and methods of using the novel complex and its constituents. The novel complexes of hK2 and PI-6 of the present invention and the PI-6 exist at an elevated level in prostate cancer tissues. PI-6 also exists at an elevated level in other types of cancer cells. Therefore, the hK2-PI6 complexes and PI-6 of the present invention may be used as a serum marker for detecting cancers, particularly prostate cancer. They may also be used as an immunohistological marker to detect prostate cancer tissues. In accordance with the present invention, the hK2-PI6 complexes of the present invention may be detected in patient tissue samples by immunohistochemical and/or in patient fluid samples by in vitro immunoassay procedures. Diagnostic methods for detecting the existence of prostate cancer is also provided.

Abstract: Formamide with low conductivity and a neutral or slightly basic pH is provided. Such formamide may be used in a sample loading solution for capillary electrophoretic separation of biomolecular analytes to enhance the efficiency of sample injection into the capillary and the intensity of the signal. Formamide of the present invention may be obtained by first purifying the formamide to a conductivity of below 7 micro mho, and then adjusting the pH of the purified formamide with a base to a range of about pH 6.5 to 7.5. The purification may be carried out by first removing the water from the formamide, and then distilling the dried formamide until the conductivity of formamide is below about 7 micro mho.

Abstract: A removable conformal liner for a centrifuge container is described. The liner has a flexible or semi-rigid body with an opening for introducing a sample. When the liner is inserted into an internal cavity of a centrifuge container, the body of the liner conforms to the interior cavity. The liner body may be made of a material that is sufficiently resilient to allow a reversible deformation of the body by folding, twisting, collapsing, rolling, or pleating. Also disclosed is a centrifuge container assembly, including a container suitable for centrifuging and a removable liner with a flexible or semi-rigid body placed into the container. The centrifuge container assembly of this invention may also have retaining-means for retaining the liner in a fixed position within the container. Also provided by the present invention is a method for separating solids from suspensions by centrifugation.

Abstract: A method of distinguishing prostate cancer from benign prostatic hyperplasia (BPH) is provided. The mathematical combination or ratio of proPSA and BPSA serum or tissue markers may be used for distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. It is the discovery of the present invention that BPSA is preferentially elevated in transition zone prostate tissue whereas pPSA is elevated in the peripheral zone of prostate tissue. A kit for aiding in distinguishing BPH from prostate cancer is also provided.

Abstract: The gene for Streptococcus pyogenes DNase B has been cloned and vectors incorporating the cloned DNA have been used to transform Escherichia coli, allowing efficient and rapid production of the DNase in E. coli without the necessity of growing large quantities of S. pyogenes. The enzyme can be produced with a leader peptide at its amino terminus. An improved method for the purification of naturally occurring S. pyogenes DNase B enzyme is also provided. The DNase B enzyme produced, either by purification of naturally occurring enzyme or by recombinant DNA techniques, can be used to generate antibodies and can also be used in immunochemical assays to detect the presence of anti-DNase B antibodies in serum as a marker of infection by S. pyogenes.

Abstract: Disclosed is a modular fluorescence sensor having the following general formula: where Fl is a fluorophore, N is a nitrogen atom, Bd1 and Bd2 are independently selected binding groups, Sp is an aliphatic spacer, and An is an anchor group for attaching the sensor to solid substrates. n=1 or 2, m=1 or 2, x is an integer, and y=1 or 2. The binding groups are capable of binding an analyte molecule to form a stable 1:1 complex. In a preferred embodiment, the Bd1 is R1—B(OH)2 and Bd2 is R2—B(OH)2. R1 and R2 are aliphatic or aromatic functional groups selected independently from each other and B is a boron atom. The present invention also provides methods of synthesizing a modular fluorescence sensor and its use in labeling solid substrates.

Abstract: A removable adapter for a centrifuge container is described. The adapter has an opening on top, an exterior surface and an interior surface. The exterior surface of the adapter body completely conforms to the bottom portion of the centrifuge container cavity. The interior surface of the adapter body has an internal sidewall and a bottom with a pellet well. The pellet well extends downwardly, toward the exterior surface. Also, an assembly is disclosed, including the adapter of the present invention with a pellet well and a liner, conforming to the interior surface of the adapter, once inside the adapter. Also provided by the present invention is a method for separating solids from suspensions by centrifugation. In this method, the removable adapter with a pellet well of the present invention is placed into a centrifuge container. Then, the suspension is placed into the centrifuge container. When centrifugation is completed, the pellet is removed from the pellet well.

Abstract: A device and method for performing a preliminary test on a neat serum sample contained in a primary collection tube is provided herein. The method includes the steps of positioning of an optical probe near the primary collection tube and monitoring the neat serum sample in the primary collection tube to determine whether an interferant, such as hemolysis, icteris and lipemia are present in the serum sample. From this test, a hemolytic index, an icteric index and a lipemic index can also be established for the neat serum sample. Based upon these serum indices, the neat serum sample can be transferred to a clinical analyzer for additional testing or to waste receptacle because the sample is compromised. Additionally, a volume test can be performed on the serum sample in the primary collection tube so that the serum sample can be properly allocated during subsequent testing.

Abstract: An article of manufacture is provided that is useful in differentiating between solutes, such as during electrophoretic separations. An embodiment of the article is a capillary tube, that carries a polymer along the inner wall of the capillary tube. The polymer is effective to reduce undesired interactions and preferably includes a polylactam that is absorbed to the surface before the surface is exposed to the solutes. A preferred polylactam is poly(vinylpyrrolidone) with a molecular weight greater than about 1,000,000 daltons (weight-average).

Abstract: Minimally invasive methods for measuring an analyte, such as glucose, contained in tile interstitial fluid of a body are provided. The methods include the steps of. (a) providing at least one sensor particle capable of generating a detectable analyte signal in responding to the analyte concentration of the body, (b) placing the sensor particle into the skin of the body for allowing the sensor particle to be in contact with the interstitial fluid of the body to generate the detectable analyte signal, (c) detecting the generated analyte signal, and (d) determining the concentration of the analyte contained in the interstitial fluid. The sensor particles may be made to be responsive to an analyte such as glucose concentration contained in a body fluid by including a photo-induced electron transfer receptor specific for the analyte in the sensor particle.

Abstract: The filling of an internally coated capillary with a gel in its polymerized state without damaging the gel. The coating prevents bonding of the gel to the inside of the capillary, The gel comprises up to 6% acrylamide and 0-5% crosslinker. The gel can be advantageously and conveniently used in automated electrophoresis systems for automatic replacement of spent gel.